HEAD OF CLINICAL DEVELOPMENT AND CLINICAL OPERATIONS

88BIOSCIENCE is a new recruitment brand specialized in Lifescience and Biotech from 88JOBS, the multi-specialist recruitment platform based in Europe and Asia. Our mission is to provide a professional, friendly and overall, reliable service for those looking for work and companies looking for staff.

Today, 88BIOSCIENCE is looking for a Head of Clinical development and Clinical operations to join a Biotech in Paris.

The hiring company: Our client is a pharma company specialized in the research and development of treatments for cancer and neurodegenerative diseases. More than 10 research projects in more than 30 countries are currently being conducted by this company.

The job responsibilities:  

• Supervise the development and execution of clinical trials (bath project management and site monitoring)
  
• Provide strategic guidance in the development and execution of the clinical development strategy.
  
• Write and validate standard operating procedures
  
• Supervise the conduct of clinical trials
  
• Develop and overseers the contract research organization's parternships (identification, selection, management of the qualification process with internal stakeholders, Validation of experience of monitoring staff allocated to our studies, management of the Master Services Agreements, Work orders and delegation letters, Development of regular communication with management, Follow of induction training, Follow of the partners’ performance: studies metrics, monitoring metrics, allocation staff, completion audit...)
  
• Leads clinical project managers and the clinical operations team.
  
• Be the primary spokesperson with the Chief Medical Officer, the Head of Pharmacovigilance and the Head of Statistics for internal and external events (steering committees, data review committees, IDMC)
  
• Support the quality management system (participation in the life cycle of procedures, declaration of non-compliances in the daily operations, following the associated corrective and preventive action plans, alerting if necessary, optimization of the processes)
  
• Ensure preparation for inspections/audits.
  
• Participate in the Executive Management Committee
  

You are the person the hiring company is looking for if you have:

• English and French fluent
  
• Scientific background
  
• 15 years of experience in clinical development in pharmaceutical companies and/or contract research organizations with experience in global development.
  
• Knowledge of local and international applicable regulation, ICH-GCP, Declaration of Helsinki, 21 CFR, …
  
• Strong business planning skills, organizational skills, leadership, communication and negotiation skills, management, computer skills in office software
  

The next steps after submitting your application:

• A 88BIOSCIENCE consultant will analyse your application and contact you
  
• The consultant will then forward your application to the recruiting company
  
• You will have a first telephone interview with the company's HRD
  
• You will have a second face to face interview with the Deputy CEO of the company
  
• You will have a last round of interview with the Executive Board of the company.
  
• You will receive a job offer
  

• Start date: as soon as possible
  
• Type of contract: Permanent
  
• Job type: full time
  
• Salary : 100-150k € per year
  
• ​Benefits: Stock options